Following a telephone conference held on August 16th (a transcript of which can be found here) between the Board and representatives of Junior Party the Broad Institute, Harvard University, and MIT (collectively, Broad) and Senior Party Sigma-Aldrich, the Board issued its Order on September 20th authorizing motions and setting times under 37 C.F.R. §§ 104(c) and 121.
The Order begins with the Board’s rejection of any of these motions being “threshold” motions (as the parties had argued), stating that “[p]atentability over the prior art is not now, and never has been, a ‘threshold issue.'” Further, the Board stated that “a holding during the course of interference that a party’s claims are unpatentable over prior art does not necessarily deprive that party of standing on the central issue of an interference—priority,” citing 37 C.F.R. § 41.201, noting that a party in an interference having claims deemed unpatentable “may still have a basis to show the opponent is not entitled to a patent because the opponent was not the first to invent the interfering subject matter.” This raises the possibility that the outcome of an interference may be that neither party is entitled to a patent on claims falling within the scope of the Interference Count.
Turning to Junior Party Broad’s motions, Broad requested in its proposed Substantive Preliminary Motion No. 1 to change the Count under 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2).* The justification here as in earlier interferences (Nos. 106,115 and 106,126) was to provide “a count broad enough to cover Broad’s best proofs, which are directed to CRISPR-Cas9 systems using dual-molecule RNA but not including a donor polynucleotide sequence.” Broad argued in the alternative a proposed Substitute Count 2:
A CRISPR-Cas9 system, for use in a eukaryotic cell, comprising:
a) a Cas9 or a nucleic acid encoding the Cas9 and
b) an RNA or a nucleic acid encoding the RNA, wherein the RNA is a dual RNA comprising a CRISPR RNA (crRNA) and a trans activating crRNA (tracrRNA) or wherein the RNA is a chimeric RNA comprising a crRNA fused to a tracrRNA,
wherein the crRNA directs the Cas9 to a target sequence in a eukaryotic cell, whereby a site-specific, double-strand break is introduced, or the target sequence is edited.
or, as in this interference as declared, claim 31 of U.S. Application No. 15/456,204.
Alternative proposed Substitute Count 3 recited:
A method comprising: introducing into, or expressing in, a eukaryotic cell having a DNA molecule,
(I) a Cas9 protein or one or more nucleotide sequences encoding the Cas9 protein;
(II) an RNA or one or more nucleotide sequences encoding the RNA, the RNA comprising: (a) a first RNA comprising a first ribonucleotide sequence and a second ribonucleotide sequence, and (b) a second RNA; and
(III) a template polynucleotide;
wherein the second RNA forms an RNA duplex with the second ribonucleotide sequence, and wherein, in the eukaryotic cell, the first ribonucleotide sequence directs the Cas9 protein to a target sequence of the DNA molecule, whereby the Cas9 cleaves both strands of the DNA molecule and the cleavage is repaired by integration of the template polynucleotide into the DNA molecule in the eukaryotic cell.
or, as in this interference as declared, claim 31 of U.S. Application No. 15/456,204; the Board notes that the first alternative portion of proposed Substitute Count 3 corresponds to Broad Application No. 16/177,403 claim 52 which has not been deemed allowable in ex parte examination.
The Board understood these proposed Substitute Counts to be directed to common subject matter directed to CRISPR-mediated DNA cleavage in eukaryotic cells and that Broad may argue that certain of its claims designated as corresponding to Count 1 in the Declaration of Interference do not correspond to Count 3. The Board GRANTED Broad’s request to be filed as BROAD MOTION 1 directed at substituting proposed Substitute Count 3 for the Count in the interference as declared.
Broad’s proposed Contingent Motion No. 1 requested leave to file a motion under 37 C.F.R. §§ 41.121(a)(1)(i) and 41.208(a)(2) to add claims in Broad applications not designated as corresponding to the Count as declared. These include claims 1, 40, and 41 of Application No. 15/160,710; claims 74, 94, and 95 of U.S. Application No. 15/430,260; and claims 52-56 of U.S Application No. 16/177,403 (although these claims have not been deemed allowable by the Office). The Board GRANTED Broad’s request to be filed as BROAD MOTION 2.
The Broad’s proposed Contingent Motion No. 2 requested leave to file a motion under 37 C.F.R. §§ 41.121(a)(1)(iii) and 41.208(a)(2), designating various claims as not corresponding to Substitute Count 3 on a variety of grounds. The Board GRANTED Broad’s request to be filed as BROAD MOTION 3.
The Board DENIED Broad’s proposed Motion No. 4 seeking judgment of unpatentability under 37 C.F.R. §§ 41.121(a)(1)(iii) on the basis that Sigma-Aldrich’s involved application (Application No. 15/456,204) is not entitled to priority benefit to its first provisional application, U.S. Application No. 61/734,256, for failing to provide an adequate written description and for failing to provide a constructive reduction to practice of the claimed subject matter. The basis for the Board’s denial was that “the motion will not further the inquiry into priority of invention of the count.” The Board DEFERRED consideration of whether to authorize a motion regarding unpatentability of Sigma-Aldrich’s claims-in-interference until the priority phase.
Instead of considering Broad’s final proposed Preliminary Motion under 37 C.F.R. § 41.121(a)(3), the Board entered an ORDER requiring both parties to provide notice of any allowed claims to the Board and the examiners of its application and DENIED this request as moot.
Finally, Broad’s request to file a motion under 37 C.F.R. § 41.208(a)(4) seeking judgment based on priority was DEFERRED until the priority phase.
For Sigma-Aldrich’s motions requests, the Board DENIED request for Motion No. 1 seeking to terminate the interference without entering judgment based on Broad lacking standing. In its Motions List, Sigma-Aldrich argued that Broad’s patents and applications having claims corresponding to the Count were not entitled to proceed because they were subject to the first-inventor-to-file provisions of the Leahy-Smith America Invents Act. Unfortunately for Sigma-Aldrich, its counsel argued during the teleconference that Broad’s claims could be subject to both the preclusions under the AIA of showing an invention date earlier than its filing date and be subject to the provisions of pre-AIA 35 U.S.C. § 102(g). The Board confessed that the basis of this argument was unclear, and that Sigma-Aldrich had not articulated a persuasive argument for why the interference was improvidently declared.
Sigma-Aldrich’s second proposed Substantive Motion was to challenge Broad’s entitlement to be accorded benefit of its provisional applications for failure to provide a constructive reduction to practice of an embodiment falling within the scope of Count 1. The Board GRANTED this request and designated this SIGMA MOTION 1.
Sigma-Aldrich’s third proposed Substantive Motion was to have the Board designate Broad’s application No. 15/330,876 as not corresponding to the Count. The Board GRANTED this request and designated this SIGMA MOTION 2.
Sigma-Aldrich’s fourth proposed Motion was for a protective order (analogous to protective orders imposed in other interferences involving CVC and Broad and these patents and applications; see “CRISPR Housekeeping” and “ToolGen Files Proposed Protective Orders in CRISPR Interferences“). The Board issued an ORDER that Sigma-Aldrich could submit a protective order to keep its Priority Statement under seal until the priority phase of the interference, suggesting Sigma-Aldrich use the protective order filed in Interference 106,115 “as reference.” The motion request was thus DENIED as moot.
Sigma-Aldrich’s request to file a motion under 37 C.F.R. § 41.208(a)(4) seeking judgment based on priority was DEFERRED until the priority phase.
In addition to these Motion requests, Sigma-Aldrich requested that the requirement under 37 C.F.R. § 41.121(d) that the parties file separate statements of material fact be waived; the Board DENIED this request. The Board GRANTED the parties’ request that the deadlines for filing and service be extended to 8 o’clock pm for filing and 11 o’clock pm, respectively, for all papers filed and served in the interference. The Board WAIVED the requirement for sequential exhibit numbers and ORDERED that exhibits could be filed within two business days of the due date for any paper in which they were cited.
The Board set out the following briefing schedule, subject to agreement by the parties to change the schedule for TIME PERIODS 1-6.
TIME PERIOD 1 ………………………………………………….29 October 2021
File (but serve one business day later) priority statements
TIME PERIOD 2 ………………………………………………..10 December 2021
File responsive motions to motions filed in TIME PERIOD 1
TIME PERIOD 3 …………………………………………………..21 January 2022
File oppositions to all motions
TIME PERIOD 4 ………………………………………………………4 March 2022
File all replies
TIME PERIOD 5 ………………………………………………………15 April 2022
File request for oral argument
File motions to exclude
TIME PERIOD 6 …………………………………………………………6 May 2022
File oppositions to motions to exclude
File response to observations
TIME PERIOD 7 ………………………………………………………..20 May 2022
File replies to oppositions to motions to exclude
DEFAULT ORAL ARGUMENT DATE ………………………………………………TBD
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